U.S. patent application number 14/195904 was filed with the patent office on 2014-10-02 for fluid cartridge for medical infusion device.
The applicant listed for this patent is Animas Corporation. Invention is credited to Daniel L. Baker, William G. Saulenas, Daniel Servansky.
Application Number | 20140296786 14/195904 |
Document ID | / |
Family ID | 50483497 |
Filed Date | 2014-10-02 |
United States Patent
Application |
20140296786 |
Kind Code |
A1 |
Servansky; Daniel ; et
al. |
October 2, 2014 |
FLUID CARTRIDGE FOR MEDICAL INFUSION DEVICE
Abstract
The invention is generally directed toward a novel fluid
cartridge for medical infusion devices. The disclosed invention
describes various protection sleeves and other structures for
protecting the luer connection of a lineset that connects to the
cartridge, to reduce the stresses placed on the luer connection
when the lineset is worn on the body of patient, and to reduce the
chances for unintentional disconnection, breakage, or leakage.
Inventors: |
Servansky; Daniel;
(Lawrenceville, PA) ; Baker; Daniel L.; (Drexel
Hill, PA) ; Saulenas; William G.; (Wayne,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Animas Corporation |
West Chester |
PA |
US |
|
|
Family ID: |
50483497 |
Appl. No.: |
14/195904 |
Filed: |
March 4, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61806470 |
Mar 29, 2013 |
|
|
|
Current U.S.
Class: |
604/152 |
Current CPC
Class: |
A61M 5/1456 20130101;
A61M 39/223 20130101; A61M 5/1415 20130101; A61M 5/1452 20130101;
A61M 5/14244 20130101; A61M 2205/121 20130101; A61M 5/1408
20130101; A61M 5/162 20130101; A61M 2039/224 20130101; A61M 5/1413
20130101 |
Class at
Publication: |
604/152 |
International
Class: |
A61M 5/145 20060101
A61M005/145; A61M 5/142 20060101 A61M005/142; A61M 5/14 20060101
A61M005/14 |
Claims
1. A medicament cartridge, comprising: a housing having an open
proximal end, a distal end, and a cavity therein defining a
reservoir; a plunger configured to slidably insert into the
proximal end of the cartridge; a luer connector at the distal end
of the cartridge, the luer connector having internal threads and a
nipple in fluid communication with the reservoir; and a two-piece
clam-shell protective cover at the distal end of the housing.
2. The cartridge of claim 1 comprising a luer configured for
screwable attachment to the luer connector.
3. The cartridge of claim 2 comprising a lineset in fluid
communication with the reservoir, secured to the nipple by the
screwable attachment of the luer to the luer connector.
4. The cartridge of claim 1 comprising an external thread disposed
on the housing.
5. The cartridge of claim 1 wherein the plunger includes one or
more o-rings seals.
6. The cartridge of claim 1 wherein the two-piece clamshell cover
comprises two half-dome shells, each half-dome shell rotatably
attached to the housing.
7. The cartridge of claim 6 wherein each half-dome shell is
rotatably attached to the housing by a living hinge.
8. A medicament cartridge, comprising: a housing having an open
proximal end, a distal end, and a cavity therein defining a
reservoir; a plunger configured to slidably insert into the
proximal end of the cartridge; a luer connector at the distal end
of the cartridge, the luer connector having internal threads and a
nipple in fluid communication with the reservoir; and a one-piece
clam-shell protective cover at the distal end of the housing.
9. The cartridge of claim 8 comprising a luer configured for
screwable attachment to the luer connector.
10. The cartridge of claim 9 comprising a lineset in fluid
communication with the reservoir, secured to the nipple by the
screwable attachment of the luer to the luer connector.
11. The cartridge of claim 8 comprising an external thread disposed
on the housing.
12. The cartridge of claim 8 wherein the plunger includes one or
more o-rings seals.
13. The cartridge of claim 8 wherein the one-piece clamshell cover
comprises a dome shell, configured to be releasably attached to the
housing.
14. The cartridge of claim 13 wherein the dome shell is releasably
attached to the housing by two or more snap-in points.
15. A medicament cartridge, comprising: a housing having an open
proximal end, a distal end, and a cavity therein defining a
reservoir; a plunger configured to slidably insert into the
proximal end of the cartridge; a luer connector at the distal end
of the cartridge, the luer connector having internal threads and a
nipple in fluid communication with the reservoir; and a telescoping
sleeve cover at the distal end of the housing, wherein the
telescoping sleeve is comprises a cylindrical member slidably
disposed concentric to the luer connector.
16. The cartridge of claim 15 comprising a luer configured for
screwable attachment to the luer connector.
17. The cartridge of claim 16 comprising a lineset in fluid
communication with the reservoir, secured to the nipple by the
screwable attachment of the luer to the luer connector.
18. The cartridge of claim 15 comprising an external thread
disposed on the housing.
19. The cartridge of claim 15 wherein the cartridge comprises a
recess concentric to the luer connector for receiving at least a
portion of the telescoping sleeve.
20. The cartridge of claim 19 wherein the telescoping sleeve
comprises one or more frictional grooves.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 61/806,470 filed on Mar. 29, 2013, the disclosure
of which is incorporated by reference herein in their
entireties.
BACKGROUND OF THE RELATED ART
[0002] The present invention relates, in general, to medical
devices and, in particular, to fluid cartridges with protected luer
connections for use with medical infusion devices.
[0003] The use of drug delivery devices for various types of drug
therapy is becoming more common as the automated infusion of a drug
may provide more reliable and more precise treatment to a
patient.
[0004] Diabetes is a major health concern, as it can significantly
impede on the freedom of action and lifestyle of persons afflicted
with this disease. Typically, treatment of the more severe form of
the condition, Type I (insulin-dependent) diabetes, requires one or
more insulin injections per day, referred to as multiple daily
injections. Insulin is required to control glucose or sugar in the
blood, thereby preventing hyperglycemia that, if left uncorrected,
can lead to ketosis. Additionally, improper administration of
insulin therapy can result in hypoglycemic episodes, which can
cause coma and death. Hyperglycemia in diabetics has been
correlated with several long-term effects of diabetes, such as
heart disease, atherosclerosis, blindness, stroke, hypertension,
and kidney failure.
[0005] The value of frequent monitoring of blood glucose as a means
to avoid or at least minimize the complications of Type I diabetes
is well established. Patients with Type II (non-insulin-dependent)
diabetes can also benefit from blood glucose monitoring in the
control of their condition by way of diet and exercise. Thus,
careful monitoring of blood glucose levels and the ability to
accurately and conveniently infuse insulin into the body in a
timely manner is a critical component in diabetes care and
treatment.
[0006] To more effectively control diabetes in a manner that
reduces the limitations imposed by this disease on the lifestyle of
the affected person, various devices for facilitating blood glucose
(BG) monitoring have been introduced. Typically, such devices, or
meters, permit the patient to quickly, and with a minimal amount of
physical discomfort, obtain a sample of their blood or interstitial
fluid that is then analyzed by the meter. In most cases, the meter
has a display screen that shows the BG reading for the patient. The
patient may then dose with the appropriate amount, or bolus, of
insulin. For many diabetics, this results in having to receive
multiple daily injections of insulin. In many cases, these
injections are self-administered.
[0007] Due to the debilitating effects that abnormal BG levels can
have on patients, i.e., hyperglycemia, persons experiencing certain
symptoms of diabetes may not be in a situation where they can
safely and accurately self-administer a bolus of insulin. Moreover,
persons with active lifestyles find it extremely inconvenient and
imposing to have to use multiple daily injections of insulin to
control their blood sugar levels, as this may interfere or prohibit
their ability to engage in certain activities. For others with
diabetes, multiple daily injections may simply not be the most
effective means for controlling their BG levels. Thus, to further
improve both accuracy and convenience for the patient, insulin
infusion pumps have been developed. These insulin delivery devices
require that a reservoir of fluid be available to be delivered to
the patient via a conduit typically referred to as an infusion set.
Various cartridge designs have historically been prone to
disconnection of the lineset that connects the lineset to the drug
reservoir, due to unprotected connection between the lineset and
the cartridge that may leak or become displaced when stressed.
[0008] It is therefore desirable to provide a structure for
connection of the lineset to the cartridge in a manner that
improves the reliability of the connection and decreases the
possibility of leakage.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings, in which like numerals
indicate like elements, of which:
[0010] FIGS. 1A and 1B illustrate a side-plan view and
cross-sectional view, respectively, of a cartridge, luer
connection, and lineset according to the prior art.
[0011] FIG. 2A illustrates a side-plan view of a cartridge with a
protected luer connection, according to an embodiment of the
present invention.
[0012] FIG. 2B illustrates a cross-sectional view of a cartridge
with a protected luer connection, according to an embodiment of the
present invention.
[0013] FIG. 2C illustrates a top-plan view of a cartridge with a
protected luer connection, according to an embodiment of the
present invention, along the line B-B of FIG. 2A.
[0014] FIG. 3A illustrates a side-plan view of a cartridge with a
protected luer connection, according to an embodiment of the
present invention.
[0015] FIG. 3B illustrates a cross-sectional view of a cartridge
with a protected luer connection, according to an embodiment of the
present invention.
[0016] FIG. 3C illustrates a top-plan view of a cartridge with a
protected luer connection, according to an embodiment of the
present invention, along the line B-B of FIG. 3A.
[0017] FIG. 4A illustrates a side-plan view of a cartridge with a
protected luer connection, according to an embodiment of the
present invention.
[0018] FIG. 4B illustrates a cross-sectional view of a cartridge
with a protected luer connection, according to an embodiment of the
present invention.
[0019] FIG. 5A illustrates a side-plan view of a cartridge with a
protected luer connection where the luer connection protection
sleeve is in an open position, according to an embodiment of the
present invention.
[0020] FIG. 5B illustrates a cross-sectional view of a cartridge
with a protected luer connection, according to an embodiment of the
present invention.
[0021] FIG. 5C illustrates a side-plan view of a cartridge with a
protected luer connection, as in FIG. 5A, where the luer connection
protection sleeve is in a closed position, according to an
embodiment of the present invention.
[0022] FIG. 6A illustrates a plan view in perspective of a
cartridge with a protected luer connection, where the protection
sleeve is shown with two finger grips.
[0023] FIG. 6B illustrates a plan view in perspective of a
cartridge with a protected luer connection according to FIG. 6A,
where the protection sleeve has multiple finger grips.
[0024] FIG. 6C illustrates a plan view in perspective of a
cartridge with a protected luer connection according to FIG. 6A,
where the protection sleeve has a knurled finger grip.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0025] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are identically numbered. The drawings, which are not
necessarily to scale, depict exemplary embodiments for the purpose
of explanation only and are not intended to limit the scope of the
invention. The detailed description illustrates by way of example,
not by way of limitation, the principles of the invention. This
description will clearly enable one skilled in the art to make and
use the invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0026] As used herein, the terms "about" or "approximately" for any
numerical values or ranges indicate a suitable dimensional
tolerance that allows the part or collection of components to
function for its intended purpose as described herein. In addition,
as used herein, the terms "patient," "host," "user" and "subject"
refer to any human or animal subject and are not intended to limit
the devices or methods to human use, although use of the subject
invention in a human patient represents a preferred embodiment.
[0027] The present invention relates to cartridges that are used in
drug delivery devices, including but not limited to insulin pumps.
For purposes of illustration, this specification will refer to the
structure and use of cartridges that store a quantity of medication
and are inserted into a drug delivery device, such as an insulin
pump, so that the medication can be infused into a patient.
[0028] Insulin pumps are devices which are typically worn on the
patient's body, either above or below their clothing. These
relatively small, unobtrusive devices typically store a quantity of
insulin in a replaceable cartridge and include a processing unit, a
display screen, and input functions such as buttons or a keypad.
Such pumps may include the ability to run multiple insulin delivery
programs, such as basal and bolus programs, to eliminate the need
for injections of insulin via needles and syringes, by providing
medication via an infusion device that can be worn by the patient
for an extended period of time, usually in the range of 1-3
days.
[0029] Patients using insulin pumps typically have the ability to
program insulin delivery times and amounts into their pump's
software, and enter their blood glucose (BG) values into the pump
via a data input system to deliver boluses of insulin in response
to their activities, such as exercise and meal intake.
Alternatively, the BG meter and pump may be in communication to
permit the meter to transmit the BG reading to the pump along with
a recommended bolus value, or to permit the pump or user to
determine the appropriate bolus of insulin, if any.
[0030] Most diabetics that use an insulin infusion device purchase
their insulin separately from the cartridges that they insert into
their infusion pump. In order to fill the cartridge, they insert a
needle attached to the cartridge into an insulin vial and pull back
on an extractor. Once filled, they insert the cartridge into the
insulin pump and attach an infusion set to the cartridge. The
portion of the infusion set that attaches to the cartridge is
generally referred to as the luer. The luer connects to tubing,
referred to as the lineset tubing, that terminates in a cannula
that is inserted under the skin of the patient to permit the
infusion of the insulin. The cannula is generally held in place
with an adhesive patch, to avoid accidental dislodgement.
[0031] The cartridge, plunger and the extractor are typically
formed from implantable grade plastic, such as long-term
implantable plastics including, but not limited to polyethylenes,
polyetheretherketones ("PEEK") and bioabsorbables-polylactic acid
("PLA"), polyglycolic acid ("PGA") and their copolymers. In
instances where the materials do not need to be of an implantable
grade, those skilled in the art will readily recognize that
numerous additional plastics that are suitable for use, including
various polyethylene and polyester acrylates and resins. Extrusion,
injection molding, and casting are typical manufacturing methods
employed for this process.
[0032] FIGS. 1A and 1B refers to a prior art device that is
exemplary of cartridges presently used to store medication and use
with an infusion device. The cartridge 100 has a body 110 with a
reservoir 190 for storing fluid. The cartridge body 110 has an
external thread 120 to allow the cartridge to be screwably secured
within a cavity within the drug delivery device (not shown).
[0033] A plunger 170 is inserted into the reservoir 190 to expel
the fluid out of the cartridge via a nipple 118. The head of the
plunger 170 is generally equipped with one or more O-rings 180,
180' to minimize leakage from between the plunger 170 and the
interior of the reservoir 190. An infusion set (partially shown)
comprising a luer 150 and lineset tubing 160 is secured to the
cartridge to permit fluid communication by screwing the luer 150
into a luer connector 115 that has internal threads for receiving
the luer 150. Once attached, the luer is secured to the cartridge
using a cartridge cap 140. An O-ring 130 is typically included to
maintain a seal between the cartridge 100 and the cavity in which
it is disposed within a drug infusion device.
[0034] The prior art device leaves the luer 150 exposed and
vulnerable to damage or breakage due to the manner in which it
protrudes from the cartridge and extends beyond the body of the
housing of the drug infusion device. An improved cartridge
according to one embodiment of the present invention is illustrated
in FIGS. 2A-2C. The improved cartridge disclosed herein provides a
protective cartridge cap integral to the cartridge that encloses
the luer and luer connection, protecting it from damage or breakage
due to shock or accidental contact.
[0035] As illustrated in FIGS. 2A-2C the cartridge 200 has a body
210 with a reservoir 290 for storing fluid. The cartridge body 210
has an external thread 220 to allow the cartridge to be screwably
secured within a cavity within the drug delivery device (not
shown). A plunger 270 is inserted into the reservoir 290 to expel
the fluid out of the cartridge via a nipple 218. The head of the
plunger 270 is generally equipped with one or more O-rings 280,
280' to minimize leakage from between the plunger 270 and the
interior of the reservoir 290.
[0036] An infusion set (partially shown) comprising a luer 250 and
lineset tubing 260 is secured to the cartridge to permit fluid
communication by screwing the luer 250 into a luer connector 215
that has internal threads for receiving the luer 250. Once the luer
is attached, the clam-shell style cap halves 240, 240' rotate via
hinges 245, 245' from an open position as illustrated in FIGS.
2A-2C into the closed position illustrated in FIGS. 3A-3C to form a
protective housing around the luer 250 and luer connector 215. An
O-ring 230 may be included to maintain a seal between the cartridge
200 and the cavity in which it is disposed within a drug infusion
device.
[0037] The clam shell configuration of FIGS. 2A-2C and 3A-3C
utilizes two half-dome shells 240, 240' which either snap into
hinges on the top of the cartridge or are molded with the cartridge
through living hinges (not shown). When the clam shell is open it
allows the user to access the luer 250 to connect the infusion
lineset 260 to the cartridge 200. When the clam shell is closed
around this fitting, it snaps into place with an eccentric locking
tab which is located on the hinge (not shown). In the closed
position, the clam shells form a structural barrier around the luer
250 and luer connector 215. Recessed pockets in the clam shells may
be used to form finger grips to allow for easy threading and
installation of the cartridge into an infusion pump. The clam
shells may be manufactured of injection molded plastics such as
acrylonitrile butadiene styrene ("ABS") for its strength and
limited shrinkage during the molding process, polypropylene for its
flexibility and application to living hinges, vinyl for its
strength and durability, nylon for its strength and resistance to
wear in the hinge application, or polycarbonate for its strength,
rigidity and cost effectiveness. Other materials may be used,
depending on the application.
[0038] Another embodiment of the invention is illustrated in FIGS.
4A-4B in which the cartridge 300 has a body 310 with a reservoir
390 for storing fluid. The cartridge body 310 has an external
thread 320 to allow the cartridge to be screwably secured within a
cavity within the drug delivery device (not shown). A plunger 370
is inserted into the reservoir 390 to expel the fluid out of the
cartridge via a nipple 318. The head of the plunger 370 is
generally equipped with one or more O-rings 380, 380' to minimize
leakage from between the plunger 370 and the interior of the
reservoir 390.
[0039] An infusion set (partially shown) comprising a luer 350 and
lineset tubing 360 is secured to the cartridge to permit fluid
communication by screwing the luer 260 into a luer connector 315
that has internal threads for receiving the luer 360. Once
attached, protective cap 340 is moved into place over the luer 350
and luer connector 315 and removably attached to the cartridge 300
by frictional forces using snap-in points 345, 345'. An O-ring 330
may be included to maintain a seal between the cartridge 300 and
the cavity in which it is disposed within a drug infusion
device.
[0040] The snap fit configuration utilizes one full-dome shell
which snaps into snap-in points 345, 345' on the top of the
cartridge 300. The user threads the infusion set luer 350 through
the top of the cap 340 before connecting the infusion lineset 360
to the nipple 318 of the cartridge 300. Once the luer connection is
made, the user snaps the cap into the snap-in points which locks
the cap into place on top of the cartridge. In the closed position,
the snap cap forms a structural barrier around the luer connection.
Recessed pockets in the snap cap form finger grips to allow for
easy threading and installation into the pump. The snap cap may be
injection molded in plastics such as ABS for its strength and
limited shrinkage during the molding process; polypropylene for its
flexibility and application to living hinges; vinyl for its
strength and durability; nylon for its strength and resistance to
wear in the hinge application; or polycarbonate for its strength,
rigidity and cost effectiveness.
[0041] Another embodiment of the invention is illustrated in FIGS.
5A-5C in which the cartridge 400 has a body 410 with a reservoir
490 for storing fluid. The cartridge body 410 has an external
thread 420 to allow the cartridge to be screwably secured within a
cavity within the drug delivery device (not shown). A plunger 470
is inserted into the reservoir 490 to expel the fluid out of the
cartridge via a nipple 418. The head of the plunger 470 is
generally equipped with one or more O-rings 480, 480' to minimize
leakage from between the plunger 470 and the interior of the
reservoir 490.
[0042] An infusion set (partially shown) comprising a luer 450 and
lineset tubing 460 is secured to the cartridge to permit fluid
communication by screwing the luer 450 into a luer connector 415
that has internal threads for receiving the luer 450. Once the luer
is attached to the luer connector, a telescoping sleeve 440 is slid
into place over the luer 450 and luer connector 415 by moving the
telescoping sleeve 440 away from the body of the cartridge 400 and
creating a friction fit between the luer 450 and the telescoping
sleeve 440. The friction fit is aided by frictional grooves 442
that permit a small portion of the luer to "lock" into the grooves.
FIG. 5A shows the telescoping sleeve 440 in an open position that
permits the luer 450 to be inserted into and secured to the luer
connector. FIG. 5C shows the telescoping sleeve 440 in a closed
position, where it frictionally secured to the luer 450, thereby
protecting the luer 450 from breakage or damage and prohibiting the
luer 450 from rotation and unintentional disconnection. An O-ring
430 may be included to maintain a seal between the cartridge 400
and the cavity in which it is disposed within a drug infusion
device.
[0043] The telescoping configuration utilizes a cylindrical sleeve
440 which fits around the luer 450 on the cartridge 400. When in
the retracted position, the user has access to the luer connection
to connect the infusion lineset 460 to the nipple 418 of the
cartridge 400. Once the connection is made, the user pulls the
cylindrical sleeve 440 upward to cover the luer 450. The
cylindrical sleeve 440 may be held in the upright position through
a tab/recess snap (e.g. frictional grooves 442) in cylindrical
sleeve. The cylindrical sleeve may have two or more finger grips,
or wings, which act as grip points to help the user pull the
cylindrical sleeve upward and then thread the cartridge 400 into an
infusion pump. The cylindrical shell may be injection molded in
plastics such as ABS for its strength and limited shrinkage during
the molding process; polypropylene for its flexibility and
application to living hinges; vinyl for its strength and
durability; nylon for its strength and resistance to wear in the
hinge application; or polycarbonate for its strength, rigidity and
cost effectiveness.
[0044] FIGS. 6A-6C illustrates embodiments according to the present
invention with differing designs for the telescoping sleeve 540.
The cartridge 500 having body 510 and external thread 520 is
attached to the luer 550 and lineset 560. FIG. 6A shows a
telescoping sleeve 540 with two finger grips 542. FIG. 6B shows a
telescoping sleeve 540 with three finger grips 544. Finally, FIG.
6C shows a telescoping sleeve 540 with a knurled finger grip
545.
[0045] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that devices and methods
within the scope of these claims and their equivalents be covered
thereby.
* * * * *